Ziagen

"For children who have had HIV-1 infection since birth, the combination drug therapies now used to treat HIV appear to protect against the heart damage seen before combination therapies were available, according to researchers in a National Instit"...

Ziagen

PATIENT INFORMATION

ZIAGEN®
(ZY-uh-jen)
(abacavir sulfate) Tablets and Oral Solution

Read this Medication Guide before you start taking ZIAGEN
and each time you get a refill. There may be new information. This information
does not take the place of talking to your healthcare provider about your
medical condition or your treatment. Be sure to carry your ZIAGEN Warning Card
with you at all times.

What is the most important information I should know
about ZIAGEN?

1. Serious allergic reaction (hypersensitivity
reaction). ZIAGEN contains abacavir (also contained in EPZICOM® and
TRIZIVIR®). Patients taking ZIAGEN may have a serious allergic reaction
(hypersensitivity reaction) that can cause death. Your risk of this allergic
reaction is much higher if you have a gene variation called HLA-B*5701. Your
healthcare provider can determine with a blood test if you have this gene
variation.If you get a symptom from 2 or more of the following groups while taking
ZIAGEN, call your healthcare provider right away to find out if you should stop
taking ZIAGEN.

Symptom(s)

Group 1

Fever

Group 2

Rash

Group 3

Nausea, vomiting, diarrhea, abdominal (stomach area) pain

Group 4

Generally ill feeling, extreme tiredness, or achiness

Group 5

Shortness of breath, cough, sore throat

A list of these symptoms is on the Warning Card your pharmacist
gives you. Carry this Warning Card with you at all times.

If you stop ZIAGEN because of an allergic reaction,
never take ZIAGEN (abacavir sulfate) or any other abacavir-containing medicine
(EPZICOM and TRIZIVIR) again. If you take ZIAGEN or any other
abacavir-containing medicine again after you have had an allergic reaction, within
hours you may get life-threatening symptoms that may include very
low blood pressure or death. If you stop ZIAGEN for any other
reason, even for a few days, andyou are not allergic to ZIAGEN, talk
with your healthcare provider before takingit again. Taking ZIAGEN
again can cause a serious allergic or life-threateningreaction, even if
you never had an allergic reaction to it before.
If your healthcare provider tells you that you can take ZIAGEN again, start
taking it when you are around medical help or people who can call a healthcare
provider if you need one.

2. Lactic Acidosis (buildup of acid in the blood).
Some human immunodeficiency virus (HIV) medicines, including ZIAGEN, can cause
a rare but serious condition called lactic acidosis. Lactic acidosis is a serious
medical emergency that can cause death and must be treated in the hospital.

Call your healthcare provider right away if you get
any of the following signs or symptoms of lactic acidosis:

you feel very weak or tired

you have unusual (not normal) muscle pain

you have trouble breathing

you have stomach pain with nausea and vomiting

you feel cold, especially in your arms and legs

you feel dizzy or light-headed

you have a fast or irregular heartbeat

3. Serious liver problems. Some people who have taken
medicines like ZIAGEN have developed serious liver problems called
hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver
(steatosis). Hepatomegaly with steatosis is a serious medical emergency that
can cause death.

Call your healthcare provider right away if you get
any of the following signs or symptoms of liver problems:

You may be more likely to get lactic acidosis or
serious liver problems if you are female, very overweight, or have been taking
nucleoside analogue medicines for a long time.

What is ZIAGEN?

ZIAGEN is a prescription medicine used to treat HIV
infection. ZIAGEN is a medicine called a nucleoside analogue reverse
transcriptase inhibitor (NRTI). ZIAGEN is always used with other anti-HIV
medicines. When used in combination with these other medicines, ZIAGEN helps
lower the amount of HIV in your blood.

ZIAGEN does not cure HIV infection or AIDS.

It is not known if ZIAGEN will help you live longer or
have fewer of the medical problems that people get with HIV or AIDS.

It is very important that you see your doctor regularly
while you are taking ZIAGEN.

Who should not take ZIAGEN?

Do not take ZIAGEN if you:

are allergic to abacavir or any of the ingredients in
ZIAGEN. See the end of this Medication Guide for a complete list of ingredients
in ZIAGEN.

have certain liver problems.

What should I tell my healthcare provider before
taking ZIAGEN?

Before you take ZIAGEN, tell your healthcare provider
if you:

have been tested and know whether or not you have a
particular gene variation called HLA-B*5701.

have hepatitis B virus infection or have other liver
problems.

have heart problems, smoke, or have diseases that
increase your risk of heart disease such as high blood pressure, high
cholesterol, or diabetes.

are pregnant or plan to become pregnant. Taking
ZIAGEN during pregnancy has not been associated with an increased risk of birth
defects. Talk to your healthcare provider if you are pregnant or plan to become
pregnant. Pregnancy Registry. If you take ZIAGEN while you are pregnant, talk to
your healthcare provider about how you can take part in the Pregnancy Registry
for ZIAGEN. The purpose of the pregnancy registry is to collect information
about the health of you and your baby.

are breastfeeding or plan to breastfeed. Do not
breastfeed if you take ZIAGEN.

You should not breastfeed if you have HIV-1 because of
the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines
you take, including prescription and nonprescription medicines, vitamins,
and herbal supplements.

Ask your healthcare provider if you are not sure if you
take one of the medicines listed above.

ZIAGEN may affect the way other medicines work, and other
medicines may affect how ZIAGEN works.

Know the medicines you take. Keep a list of your
medicines with you to show to your healthcare provider and pharmacist when you
get a new medicine.

How should I take ZIAGEN?

Take ZIAGEN exactly as your healthcare provider tells
you to take it.

ZIAGEN is taken by mouth as a tablet or a strawberry-
and bananaflavored liquid.

ZIAGEN may be taken with or without food.

Do not skip doses.

Children aged 3 months and older can also take ZIAGEN.
The child's healthcare provider will decide the right dose and whether the
child should take the tablet or liquid, based on the child's weight. The dose
should not be more than the recommended adult dose.

Do not let your ZIAGEN run out.If you stop your anti-HIV medicines, even for a short time, the amount of
virus in your blood may increase and the virus may become harder to treat. If
you take too much ZIAGEN, call your healthcare provider or poison control
center or go to the nearest hospital emergency room right away.

What are the possible side effects of ZIAGEN?

ZIAGEN can cause serious side effects including
allergic reactions, lactic acidosis, and liver problems. See “What is the
most important information I should know about ZIAGEN?”

Changes in immune system (Immune Reconstitution
Syndrome). Your immune system may get stronger and begin to fight
infections that have been hidden in your body for a long time. Tell your
healthcare provider if you start having new or worse symptoms of infection
after you start taking ZIAGEN.

Changes in body fat (fat redistribution). Changes
in body fat (lipoatrophy or lipodystrophy) can happen in some people taking
antiretroviral medicines including ZIAGEN.
These changes may include:

more fat in or around your trunk, upper back and neck
(buffalo hump), breast, or chest

Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.

These are not all the possible side effects of ZIAGEN.
For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZIAGEN?

Store ZIAGEN at room temperature, between 68°F to 77°F
(20°C to 25°C).

Do not freeze ZIAGEN.

Keep ZIAGEN and all medicines out of the reach of
children.

General information for safe and effective use of
ZIAGEN

Avoid doing things that can spread HIV infection to
others.

Do not re-use or share needles or other injection
equipment.

Do not share personal items that can have blood or
body fluids on them, like toothbrushes and razor blades.

Do not have any kind of sex without protection. Always
practice safe sex by using a latex or polyurethane condom to lower the chance
of sexual contact with any body fluids such as semen, vaginal secretions, or
blood.

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use ZIAGEN for a condition for
which it was not prescribed. Do not give ZIAGEN to other people, even if they
have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important
information about ZIAGEN. If you would like more information, talk with your
healthcare provider. You can ask your healthcare provider or pharmacist for the
information that is written for healthcare professionals.